The Effect Of Light On Scar Appearance | NCT00544635

Studies
The Effect Of Light On Scar Appearance

NCT00544635

Sponsor

Northwestern University

Status

Terminated

Last Update Posted

Jul 29, 2014Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Cutaneous Scars

Interventions

no intervention
light

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study personnel left institution before study completion.

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Oct 12, 2007

First Submission Date that Met QC Criteria

Oct 12, 2007

First Posted Date

Oct 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2014

Last Update Posted Date

Jul 29, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this project is to examine the ability of light exposure to improve the appearance of cutaneous scars.

Detailed Description

Light would be efficacious in improving scar appearance due to its known effects on wound healing, acne, and its use for skin rejuvenation. Light interacts with cells and stimulates the production of new collagen and elastin. This same energy can be used to inhibit collagen formation and help improve scars.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	scars will be treated with light	Device: light
B	Placebo Comparator	no intervention	Device: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Device	no intervention	B
light

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scar vascularity		24 weeks
Scar pigmentation		24 weeks
Scar thickness		24 weeks
Scar length		24 weeks
Scar width		24 weeks
Scar surface area		24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have two lesions that have been selected for excision
Have two cutaneous scars from previous excisions as part of a standard of care
Subjects are in good health
Subject has a willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion Criteria:

Pregnancy or lactation
Subjects who are unable to understand the protocol or to give informed consent
Subjects with mental illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Murad Alam, MD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Memorial Hospital		Chicago	Illinois	60611	United States

Intervention Browse Module

MeSH Terms

ID	Term
D014467	Ultraviolet Therapy

Ancestor Terms

ID	Term
D010789	Phototherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided